Efficacy of 17α-ethynylestradiol-3-sulfate for severe hemorrhage in minipigs in the absence of fluid resuscitation.

Background: Of the potentially survivable US battlefield deaths from 2001 to 2011, 80% to 91% were caused by severe hemorrhage. We subjected minipigs to acute severe blood loss, administered a single dose of 17α-ethynylestradiol-3-sulfate (EE-3-SO4) without resuscitative fluids, and determined survival as well as cardiovascular, biochemical, and physiologic response parameters.

Methods: Following controlled removal of 60% circulating blood volume over 1 hour, minipigs received EE-3-SO4 at 0, 1, 3, or 5-mg/mL saline per kilogram of body weight in Experiment 1 (n = 25) and 0-, 0.

Challenges in the development of prescription opioid abuse-deterrent formulations.

Opioid analgesics remain the cornerstone of effective management for moderate-to-severe pain. In the face of persistent lack of access to opioids by patients with legitimate pain problems, the rate of prescription opioid abuse in the United States has escalated over the past 15 years. Abuse-deterrent opioid products can play a central role in optimizing the risk-benefit ratio of opioid analgesics--if these products can be developed cost-effectively without compromising efficacy or creating new safety issues for the target treatment population.

Impact of formulation on the abuse liability, safety and regulation of medications: the expert panel report.

A scientific meeting was held in April 2005 to consider how the formulation of medications might impact on their potential for abuse. The background papers prepared for this meeting, as well as abstracts of volunteered presentations, are published in this supplemental issue of Drug and Alcohol Dependence. This paper is the Expert Panel Report summarizing the discussions held following the formal presentations and including the suggested recommendations for additional research that emerged from these discussions.

Involving the pharmaceutical and biotech communities in medication development for substance abuse.

Pharmacotherapy as adjunctive treatment is an integral part of the strategy for treating substance abuse. Although there are several approved drugs for the treatment of opioid, alcohol, and nicotine dependence, the pharmaceutical industry, for a variety of reasons, has been reluctant to enter this area to develop medications for substance abuse indications. Therefore, in 1990, a Medication Development Program was established by NIDA to carry out and assist in stimulating development of new pharmacotherapies.

Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999.

Purpose: Risks and benefits of marketed drugs can be improved by changing their labels to optimize dosage regimens for indicated populations. Such postmarketing label changes may reflect the quality of pre-marketing development, regulatory review, and postmarketing surveillance. We documented dosage changes of FDA-approved new molecular entities (NMEs), and investigated trends over time and across therapeutic groups, on the premise that improved drug development methods have yielded fewer postmarketing label changes over time.